CHICAGO — Updated results from the BRAIN study showed that there were no new safety signals and 16% of patients with relapsed glioblastoma treated with bevacizumab plus irinotecan were alive at 2.5 years.
Timothy Cloughesy, MD, director of the UCLA Neuro-Oncology Program at the Ronald Reagan UCLA Medical Center, updated results first presented in 2007 during the 2010 ASCO Annual Meeting.
BRAIN is a phase 2, open-label, multicenter, randomized, non-comparative trial evaluating bevacizumab (Avastin, Genentech) alone or in combination with irinotecan for glioblastoma at first or second relapse. Eighty-five patients were assigned bevacizumab monotherapy and 82 were assigned combination treatment. Eligible patients in the bevacizumab arm who progressed were allowed to crossover to the combination arm in the post-progression phase.
Cloughesy said safety data was little changed from the previous presentation. Grade-3/grade-4 hypertension was 10.7% in the monotherapy group vs. 3.8% in the combination group and 0% in the crossover arm.
“The adverse events that we’re most concerned about with patients taking anti-VEGF therapy — cerebral hemorrhage, wound healing, arterial thromboembolism and gastrointestinal perforation — all stayed fairly low,” he said. “There was no significant change from the prior data presented.”
At 30 months, 11% of patients in the monotherapy group were still alive compared with 16% in the combination group. Median OS was 9.3 months in the bevacizumab arm vs. 8.9 months in the combination arm. – by Jason Harris